Reshaping real-world data sharing with Blockchain-based system

“[Blockchain] is a complicated technology and one whose full potential is not necessarily understood by healthcare players. We want to demonstrate […] precisely that blockchain works when you work on the uses!” Nesrine Benyahia, Managing Director of DrData

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Access to real-world health data is becoming an increasingly important issue for pharmaceutical companies and facilitating the acquisition of this data could make the development of new drugs faster and less costly. After explaining the practices of data acquisition in the pharmaceutical industry, and the current initiatives aiming at facilitating them, this article will then focus on the projects using the Blockchain, in the exchange, monetization and securing of these precious data.

Use of real-world data by the Pharmaceutical Industry, where do we stand?

Real-world data are commonly defined as data that are not collected in an experimental setting and without intervention in the usual way patients are managed, with the aim of reflecting current practice in care. These data can sometimes complement data from randomized controlled trials, which have the disadvantage of being true only in the very limited context of clinical trials. The use of real-world data is likely to grow for two key reasons. First, new technological tools allow us to collect them (connected medical devices, for example) while others allow us to analyze them (data science, text-mining, patient forums, exploitation of grey literature, etc.). Secondly,  for a few years now, we have been observing a regulatory evolution that allows more and more early access and clinical evidence on small number of patients (especially in the case of cancer drug trials) and that tends to move the evidence cursor towards real-world data.

The uses of real-world data are varied and concern the development of new drugs – in particular in order to define new management algorithms, or to discover unmet medical needs through the analysis of databases – but also the monitoring of products already on the market – we can cite several cases of use such as the monitoring of safety and use, access to the market with conditional financial support or payment on performance. These data can be used to inform the decisions of health authorities and also the strategic decisions of pharmaceutical companies.

Current acquisition and use of real-world data: Data sources are varied, with varying degrees of maturity and availability, as well as varying access procedures. Some of these data come directly from healthcare, such as data from medico-administrative databases or hospital information systems, while others are produced directly by patients, through social networks, therapy management applications and connected medical devices. Access to this data for the pharmaceutical industry takes place in various ways. Like many other countries, France is currently working to implement organizational and regulatory measures to facilitate access to this real-world data, and to organize its collection and use, notably with the creation of the Health Data Hub. However, to this day, in the French and European context, no platform allows patients to have access to all of their health data and to freely dispose of them in order to participate in a given research project.

Imagining a decentralized health data sharing system, the first steps:

As a reminder, blockchain is a cryptographic technology developed in the late 2000s that allows to store, authenticate, and transmit information in a decentralized (without intermediaries or trusted third parties), transparent and highly secure way. For more information about how blockchain works, please refer to our previous article about this technology: “Blockchain, Mobile Applications: Will technology solve the problem of counterfeit drugs?” As we already explained in that article, the young Blockchain technology has so far mainly expressed its potential in the field of crypto currencies, but it is possible to imagine many other applications.

Thus, several research teams are working on how this technology could potentially address the major challenges of confidentiality, interoperability, integrity, and secure accessibility – among others – posed by the sharing of health data.

These academic research teams have envisioned blockchains that bring together different stakeholders: healthcare services, patients, and data users (who may be the patients themselves or other healthcare-producing organizations). These systems do not provide data to third parties (industrialists, for example); their only objectives are to improve the quality of care and to offer patients a platform that brings together their fragmented health data: in the United States, data is siloed because of the organization of the health system; in France, although the Social Security system has a centralizing role, the “Mon Espace Santé” service, which allows patients to access all of their data and is a descendant of the Shared Medical Record, is slow to be implemented.

These academic projects propose, on the one hand, to store medical information on a private blockchain – and on the other hand to operate Smart Contracts with different uses. Smart Contracts are computerized equivalents of traditional contracts, but they are different because their execution does not require a trusted third party or human intervention (they are executed when the conditions provided by the computer code are met). In these proposals for real-world data sharing systems, they allow, among other things, to authenticate the identity of the users, to guarantee the integrity of the data, their confidentiality, and the flexibility of their access (unauthorized persons cannot access the patient data).

Despite their theoretical qualities, these academic projects do not integrate the possibility for patients to share their data in an open access fashion, to different research projects. In the last part of this article, we will review two examples of start-ups seeking to address this issue using the Blockchain.

Examples of two blockchain projects that allow patients to share their health data:

Embleema is a startup that offers a platform where patients can upload their health data – ranging from their complete genome to the results of their medical tests, to data from connected medical devices. At the same time, pharmaceutical companies can express their needs, and an algorithm on the platform will then select patients who could correspond to this need, by their pathology or by the treatments they are prescribed. They will then be asked to sign a consent document to participate in an observational study, in exchange for which they will be paid (in the USA) or may choose a patient association that will receive funding (in France).  The data produced by patients are stored on centralized servers of specialized health data hosts, and only the industrialists who have purchased it have access to it. The Ethereum blockchain and its system of smart contracts are used in the Embleema model only to certify compliance and organize the sharing of documents related to the study (collection of patient consent, etc.). We can therefore wonder about the added value of the blockchain in this model. Couldn’t these documents have been stored on centralized servers? And the actions triggered by the smart contracts carried out from a centralized database, with Embleema acting as a trusted third party? How much of the marketing use of the term Blockchain is in this model? In any case, the Patient Truth platform developed by Embleema has the great merit of proposing a model in which patients have control over their health data, and the choice to get involved in this or that academic or industrial research project.

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The second company we will focus on is MedicalVeda, a Canadian start-up in which blockchain plays a more central role, including the launch of an ERC-20 token (a standard cryptocurrency using the Ethereum blockchain that can be programmed to participate in a Smart Contract). The workings of this company, which seeks to solve several problems at once – regarding access to healthcare data by the healthcare industries but also about access to care on the patient side – is quite complex and conceptual and we will try to simplify it as much as possible. MedicalVeda’s value proposition is based on several products:

• The VEDA Health Portal, which is a platform to centralize patient’s health data for the benefit of caregivers and pharmaceutical industry research programs to which the patient can choose to provide access. Similar to the projects previously mentioned in this article, the goal is to overcome the challenge of data siloing. The data is secured by a private blockchain.
• The Medical Veda Data Market Place, which aims to directly connect patients and pharmaceutical companies according to their needs. Transactions are made using the blockchain and are paid for in crypto-currencies.
• Two other products are worth mentioning: the MVeda token, which is the cryptocurrency of the data sales platform, which pays patients, and Medfi Veda, a decentralized finance system that allows American patients to borrow money to fund medical interventions by collateralizing their MVeda crypto-currency tokens. This collateral lending system is classic in decentralized finance, but admittedly the details of the system developed by MVeda remain murky. The objective of the system is to allow patients to collateralize their health data in order to facilitate their access to healthcare.

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In conclusion, Blockchain is still a young technology that experienced a very high level of interest in the healthcare world in 2018 before gradually drying up since then, mainly due to a misunderstanding of its potential and a lack of education of healthcare professionals on the subject on the one hand, and on the other hand due to too much marketing use of what had become a “buzz-word.” The intrinsic qualities of this technology make it possible to imagine creative and ambitious models for sharing health data, which may be the source of accelerated development of new drugs in the future. For this time being, and despite courageous and intelligent initiatives, some of which have already been commercialized, no solution is fully functional on a very large scale; everything remains to be built.

To go further:

• Bernard Bégaud, Dominique polton, Franck von Lennep; Real-world data, a major challenge for the quality of care and the regulation of the healthcare system, the example of medicines; Report commissioned by the French Minister of Health, Marisol Touraine
• Liu, Z. Wang, C. Jin, F. Li and G. Li, “A Blockchain-Based Medical Data Sharing and Protection Scheme,” in IEEE Access, vol. 7, pp. 118943-118953, 2019, doi: 10.1109/ACCESS.2019.2937685.
• Huihui Yang, Bian Yang; A blockchain-based approach to the secure sharing of Healthcare data; NIK-2017 conference; see http://www.nik.no/.
• Embleema, the blockchain between patients and researchers: https://www.latribune.fr/technos-medias/innovation-et-start-up/la-startup-de-la-semaine-embleema-la-blockchain-entre-patients-et-chercheurs-832120.html
• MedicalVeda Announces a Defi Based Medical Health Care Protocol: https://www.globenewswire.com/news-release/2020/09/26/2099560/0/en/MedicalVeda-Announces-a-Defi-Based-Medical-Health-Care-Protocol.html
• MedicalVeda White Paper V2.0 – Redefining patient journey by harnessing the power of Blockchain, AI and Smart Contracts, https://medicalveda.com/